News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?

Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market

Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.

One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.

Announced in a May 2016 statement,  the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).

Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner? (more…)

Research Study Involving Northwestern Medicine and Harvard Indicates that Telomeres Could Be the Next Biomarker Pathologists and Clinical Labs Use to Detect Cancer

Researchers demonstrate that the length of blood telomeres may follow a specific pattern before cancer is detectable, which could lead to new diagnostic tests for detecting cancer in its early stages

Pathologists and Clinical pathology laboratories could soon have another tool to aid in the early detection of cancer. New research findings indicate that telomeres could serve as biomarkers for cancer if the right testing is done at the right times.

This study was conducted by Northwestern Medicine, (a collaboration between Northwestern Memorial HealthCare and Northwestern University Feinberg School of Medicine) and Harvard University. It was titled “Blood Telomere Length Attrition and Cancer Development in the Normative Aging Study Cohort”. The findings bring scientists a step closer to understanding how telomeres change with the onset of cancer.

Predictive Biomarker for Cancer Might Be Used in Clinical Lab Testing

“Understanding this pattern of telomere growth may mean it can be a predictive biomarker for cancer,” said Lifang Hou, MD, PhD, the study’s lead author and a professor of preventive medicine at Northwestern University Feinberg School of Medicine in a Northwestern Medicine news release. “Because we saw a strong relationship in the pattern across a wide variety of cancers, with the right testing these procedures could be used to eventually diagnose a wide variety of cancers.” (more…)